Validation Engineer
Core
Coordinate, implement, and maintain the site validation program for equipment, facilities, utilities, processes, and software in compliance with regulatory standards.
Role type
Validation Engineer (cGMP pharmaceutical manufacturing)
Builds
Qualified computerized systems, validated equipment/facilities/utilities/processes, validation documentation (Master Plans, Project Plans, protocols, reports)
Domain
Pharmaceutical manufacturing / Regulatory compliance
Required skills
cGMP compliance knowledge, validation program coordination, protocol and report writing, change control management, regulatory adherence (FDA/European cGMP/GAMP)
Preferred skills
None stated
Technologies
None stated
Responsibilities
Coordinate the site Validation Program; Ensure computerised systems are qualified per Data Integrity policies; Generate/maintain Validation Master Plans and Project Validation Plans; Write validation protocols and final reports to cGMP standard; Manage validation change control process
Seniority
Mid-level, hands-on IC
